Abstract

Many emerging health technologies have relatively limited evidence and unique properties and effects (e.g. innovative combinations, linked to genetic markers) to be evaluated in HTA. These challenges have become barriers to efficient evidence-based decision-making. To address these challenges, novel HTA methods are needed. The aim of the study, in the context of H2020 HTx project (HTx), was to construct a framework for the innovation of HTA methods (the IHTAM framework) to guide interdisciplinary development and implementation of HTA methods. The IHTAM framework was constructed in two stages. (1) A scoping review of existing HTA frameworks and a scoping review of frameworks outside the HTA field were conducted to identify and synthesize the concepts on how to innovate an HTA method. (2) Based on the concepts from the scoping reviews, the IHTAM framework was iteratively developed by the authors in six brainstorming sessions and validated by the HTx participants in two workshops. The IHTAM framework includes three phases (i.e. identifying the needs for, developing, and implementing novel HTA methods) and ten subphases. Important implications of the IHTAM framework include: (1) dynamically defining and engaging the stakeholders who can develop, execute, decide on the application and redesign of, or be affected by an HTA method; (2) testing the transferability and tailoring the design of an HTA method to the needs of HTA stakeholders from the beginning of the innovation process; (3) setting up decision-making criteria, as well as a decision-making system, to efficiently apply and transfer a method to a local setting. The development of the IHTAM framework provides a starting point for HTA stakeholders to understand how to innovate HTA methods. The framework will be further developed by testing its applicability in various contexts of innovating new HTA methods both in HTx and other research consortiums.

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